Back to resultsEnhanced Kidney Follow-up for AKI Survivors in Care Transitions
Primary Purpose
Acute Kidney Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education
Education and follow-up
Sponsored by
About this trial
This is an interventional health services research trial for Acute Kidney Injury focused on measuring transitions of care, education, patient reported outcomes, chronic kidney disease, acute kidney injury
Eligibility Criteria
Inclusion Criteria:
- KDIGO Stage 3 AKI
- Primary care provider at Mayo Rochester.
Exclusion Criteria:
- Patient with need for dialysis at discharge from hospital or hospice.
- Enrolled in the Primary Care Transition Program.
- Non-English speaking.
- Cognitive impairment.
- Dementia.
- Mini-Cog score of less than 3.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Usual care
Education alone
Education and follow-up
Arm Description
Outcomes
Primary Outcome Measures
Modified Kidney Knowledge Survey (mKIKS)
Assesses participants' objective knowledge about AKI causes, risk factors, and management. The minimum score is 0, maximum score is 15, higher scores indicate greater knowledge.
Secondary Outcome Measures
Brief health literacy screen
A 4-item tool to assess health literacy. Minimum score of 0, maximum score 20, higher scores indicate higher health literacy
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10
Based on the provided responses, an overall summary score, and two subset scores - Global health physical and Global health mental can be calculated. Raw summed score are converted into T-scores. Higher scores indicate better health.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04505891
Brief Title
Enhanced Kidney Follow-up for AKI Survivors in Care Transitions
Official Title
Enhanced Kidney Follow-up for AKI Survivors in Care Transitions (The ACT Study): Impact on Patient Reported Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
December 21, 2021 (Actual)
Study Completion Date
December 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the ability of education and outpatient kidney care follow-up in order to improve patient knowledge about acute kidney injury (AKI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
transitions of care, education, patient reported outcomes, chronic kidney disease, acute kidney injury
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
No Intervention
Arm Title
Education alone
Arm Type
Active Comparator
Arm Title
Education and follow-up
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Kidney health education will be delivered prior to discharge by trained nurse educators.
Intervention Type
Behavioral
Intervention Name(s)
Education and follow-up
Intervention Description
In patients allocated to the education and follow-up arm, education along with a a post-discharge healthcare visit from a multidisciplinary care team will be performed.
Primary Outcome Measure Information:
Title
Modified Kidney Knowledge Survey (mKIKS)
Description
Assesses participants' objective knowledge about AKI causes, risk factors, and management. The minimum score is 0, maximum score is 15, higher scores indicate greater knowledge.
Time Frame
14-days after last study contact
Secondary Outcome Measure Information:
Title
Brief health literacy screen
Description
A 4-item tool to assess health literacy. Minimum score of 0, maximum score 20, higher scores indicate higher health literacy
Time Frame
30-days post hospitalization
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10
Description
Based on the provided responses, an overall summary score, and two subset scores - Global health physical and Global health mental can be calculated. Raw summed score are converted into T-scores. Higher scores indicate better health.
Time Frame
30-days post hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
KDIGO Stage 3 AKI
Primary care provider at Mayo Rochester.
Exclusion Criteria:
Patient with need for dialysis at discharge from hospital or hospice.
Enrolled in the Primary Care Transition Program.
Non-English speaking.
Cognitive impairment.
Dementia.
Mini-Cog score of less than 3.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin F Barreto, PharmD, RPh
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Enhanced Kidney Follow-up for AKI Survivors in Care Transitions
We'll reach out to this number within 24 hrs